Sr Director, Quality Large Molecule

Position Overview

• Location Type: [Not Specified]
• Job Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Salary: [Not Specified]

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

The Senior Director Quality, Large Molecule is an executive level leadership role responsible to ensure important medicines are manufactured safely and delivered on time for patients around the world, while ensuring all Quality standards, regulatory requirements and customer expectations are maintained. The Senior Director will champion and pursue and promote a premier quality culture and assure the organization delivers on the mission, goals and objectives.

Key Responsibilities

• Ensure Quality policy and objectives are understood, implemented and maintained at all levels in the organization.
• Develop short and long-term plans to achieve both quality and business objectives in accordance with policies.
• Develop and implement positive company image and relationships with key customers, vendors and regulators; will personally be involved with the management of key accounts; will represent the company as appropriate in its relationships with external entities.
• Emphasize the critical need for on-time delivery through the lens of full compliance across all levels of the organization.
• Encourage a right-first-time culture.
• Ensure quality standards are understood and implemented throughout the organization.
• Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS); to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement.
• Ensuring inspection readiness of operations, including preparation to regulatory inspections.
• Interface regulatory authorities and ensure the company is appropriately represented.
• Develop resource strategies, allocate budget, staff, tools and specialized support necessary for efficient operations.
• Ensure consistency, standardization, efficiency, and cost-effectiveness of approaches while maintaining compliance with regulatory and clients’ expectations.
• Ensuring PPI (Practical Process Improvement) is adopted across the quality organization.

Minimum Qualifications

• B.S. Degree in business or a scientific/technical field required. Advanced degree is a plus.
• Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering multi-site Operations/Quality roles with global experience.
• Extensive cGMP knowledge required.
• Previous experience with Large Molecule manufacturing preferred.
• Able to optimally collaborate with others.
• Ability to lead, empower and influence others within a remote team, and experience developing others.
• Ability to travel globally (30% minimum).